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A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection

Primary Purpose

Urinary Tract Infections

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

RO7079901

Meropenem

About this trial

This is an interventional treatment trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis)
Clinical signs and/or symptoms of pyelonephritis or a cUTI
Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (>)1x10^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism
Negative urine pregnancy test result confirmed by a blood test
Agreement to remain abstinent or use a contraceptive method

Exclusion Criteria:

Has a concomitant infection requiring antibacterial therapy, in addition to study drug
Confirmed fungal urinary tract infection
Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant
Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy
Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period
Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry
Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis)
Suspected or confirmed perinephric or intra renal abscess
Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion
History of epilepsy, brain lesions or other significant neurological disorders
Use of probenecid within the 7 days before enrollment
Known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic
Any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study
Women who are pregnant, planning to become pregnant, or lactating
Participation in a clinical study of an investigational drug or device within one month prior to enrollment
Prior enrollment in this study

Sites / Locations

eStudySite
Jacksonville Center For Clinical Research
Semmelweis University, First Dept of Medicine
Szent Imre Egyetemi Oktatokorhaz
Kenezy Gyula Korhaz-Rend. Eges. Szol.; Klinikai Farm. Infek. es Allerg. Intezet
Liepaja Regional hospital
P.Stradina Kliniska Uni Tes Slimnica; Latvian Center of Nephrology
Riga East clinical university hospital
Klinika Urologii Ogólnej: Collegium Medicum Uniwersytetu Mikołaja Kopernika w Toruniu; Urology
Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii
Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek
Clinical Center of Serbia; Clinic of Urology
Clinical Center Zemun
Clinical Hospital Center Bezanijska Kosa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RO7079901 and Meropenem

Arm Description

Participants will receive RO7079901 and meropenem. The duration of study drug treatment will be determined by the investigator after evaluation of the participant's response to study drug treatment. Participants should receive a minimum treatment period of 3 days and up to 14 days of intravenous (IV) study drug treatment.

Outcomes

Primary Outcome Measures

Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901

Total Clearance (CL) of RO7079901

Renal Clearance (CLr) of RO7079901

Maximum Observed Plasma Concentration (Cmax) of RO7079901

Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901

Fraction Excreted into the Urine (Fe) of RO7079901

Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901

Steady State Volume of Distribution (Vss) of RO7079901

Secondary Outcome Measures

AUC0-tau of Meropenem

CL of Meropenem

CLr of Meropenem

Cmax of Meropenem

Ae of Meropenem

Fe of Meropenem

Tmax of Meropenem

Vss of Meropenem

Full Information

NCT ID

NCT03174795

First Posted

May 31, 2017

Last Updated

May 11, 2018

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03174795

Brief Title

A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection

Official Title

A Non-Randomized, Open-Label, One Treatment, One Group Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Patients With a Complicated Urinary Tract Infection

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

July 11, 2017 (Actual)

Primary Completion Date

December 4, 2017 (Actual)

Study Completion Date

December 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cUTI) including pyelonephritis to characterize the pharmacokinetics of RO7079901 co-administered with meropenem.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RO7079901 and Meropenem

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

RO7079901

Intervention Description

Participants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days.

Intervention Type

Drug

Intervention Name(s)

Meropenem

Intervention Description

Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days.

Primary Outcome Measure Information:

Title

Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

Total Clearance (CL) of RO7079901

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

Renal Clearance (CLr) of RO7079901

Time Frame

Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

Title

Maximum Observed Plasma Concentration (Cmax) of RO7079901

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901

Time Frame

Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

Title

Fraction Excreted into the Urine (Fe) of RO7079901

Time Frame

Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

Title

Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

Steady State Volume of Distribution (Vss) of RO7079901

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Secondary Outcome Measure Information:

Title

AUC0-tau of Meropenem

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

CL of Meropenem

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

CLr of Meropenem

Time Frame

Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

Title

Cmax of Meropenem

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

Ae of Meropenem

Time Frame

Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

Title

Fe of Meropenem

Time Frame

Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)

Title

Tmax of Meropenem

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

Title

Vss of Meropenem

Time Frame

Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis) Clinical signs and/or symptoms of pyelonephritis or a cUTI Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (>)1x10^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism Negative urine pregnancy test result confirmed by a blood test Agreement to remain abstinent or use a contraceptive method Exclusion Criteria: Has a concomitant infection requiring antibacterial therapy, in addition to study drug Confirmed fungal urinary tract infection Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis) Suspected or confirmed perinephric or intra renal abscess Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion History of epilepsy, brain lesions or other significant neurological disorders Use of probenecid within the 7 days before enrollment Known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic Any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study Women who are pregnant, planning to become pregnant, or lactating Participation in a clinical study of an investigational drug or device within one month prior to enrollment Prior enrollment in this study

Facility Information:

Facility Name

eStudySite

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Jacksonville Center For Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Semmelweis University, First Dept of Medicine

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Szent Imre Egyetemi Oktatokorhaz

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

Facility Name

Kenezy Gyula Korhaz-Rend. Eges. Szol.; Klinikai Farm. Infek. es Allerg. Intezet

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Liepaja Regional hospital

City

Liepaja

ZIP/Postal Code

3414

Country

Latvia

Facility Name

P.Stradina Kliniska Uni Tes Slimnica; Latvian Center of Nephrology

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Riga East clinical university hospital

City

Riga

ZIP/Postal Code

LV1006

Country

Latvia

Facility Name

Klinika Urologii Ogólnej: Collegium Medicum Uniwersytetu Mikołaja Kopernika w Toruniu; Urology

City

Bydgoszcz

ZIP/Postal Code

85-094

Country

Poland

Facility Name

Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii

City

Warszawa

ZIP/Postal Code

02-005

Country

Poland

Facility Name

Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek

City

Łódź

ZIP/Postal Code

92-213

Country

Poland

Facility Name

Clinical Center of Serbia; Clinic of Urology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Center Zemun

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Clinical Hospital Center Bezanijska Kosa

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

12. IPD Sharing Statement

Learn more about this trial

A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection

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